The present invention relates to improved bearings for use in orthopaedic implant prosthesis and particularly to methods for making ultra high molecular weight polyethylene (hereinafter, UHMWPE) bearings by molding a cross-linked preform by the application of sufficient heat and pressure.
Such UHMWPE resin is commonly used for bearings in hip, knee, shoulder and elbow prostheses. Typically, the bearings may be formed by direct compression molding processes or by machining the required bearing shapes from mill shapes such as sheet or bar stock. Typically, the stock or the molded bearings are irradiated and subsequently heat treated or heat annealed. The irradiation generates molecular cross-links and free radicals. The free radicals are subsequently eliminated by the heat treating processes.
Reference is made to a number of prior art references as follows:
U.S. Patents:
1. U.S. Pat. No. 5,414,049, Non-Oxidizing Polymeric Medical Implant, to Deh-Chuan Sun, et al.
2. U.S. Pat. No. 5,449,745, Non-Oxidizing Polymeric Medical Implant, to Deh-Chuan Sun, et al.
3. U.S. Pat. No. 5,543,471, Non-Oxidizing Polymeric Medical Implant, to Deh-Chuan Sun, et al.
4. U.S. Pat. No. 5,650,485, Non-Oxidizing Polymeric Medical Implant, to Deh-Chuan Sun, et al.
5. U.S. Pat. No. 5,728,748, Non-Oxidizing Polymeric Medical Implant, to Deh-Chuan Sun, et al.
6. U.S. Pat. No. 4,586,995, Polymer and Irradiation Treatment Method, to James C. Randall.
7. U.S. Pat. No. 5,153,039, High Density Polyethylene Article with Oxygen Barrier Properties, to Jay P. Porter, et al.
8. U.S. Pat. No. 5,508,319, High Melt Strength, Ethylene Polymer, Process for Making It, and Use Thereof, to Anthony J. DeNicola, Jr. et al.
9. U.S. Pat. No. 3,352,818, Stability of Polyolefines, to Gerhard Meyer, et al.
10. U.S. Pat. No. 5,577,368, Method for Improving Wear Resistance of Polymeric Bioimplantable Components, to John V. Hamilton, et al.
11. U.S. Pat. No. 5,753,182, Method for Reducing the Number of Free Radicals Present in Ultrahigh Molecular Weight Polyethylene Orthopedic Components, to Joel Higgins.
12. U.S. Pat. No. 5,709,020, Method for Reducing the Generation of Wear Particulates From an Implant, to David A. Pienowski, et al.
13. U.S. Pat. No. 5,702,456, Implant Having Reduced Generation of Wear Particulates, to David A. Pienowski.
14. U.S. Pat. No. 5,515,590, Method for Reducing the Generation of Wear Particulates From an Implant, David A. Pienowski.
15. U.S. Pat. No. 5,593,719, Treatments to Reduce Frictional Wear Between Components Made of Ultra-High Molecular Weight Polyethylene and Metal Alloys, Geoffrey Dearnaley, et al.
16. U.S. Pat. No. 4,366,618, Bone Connective Prosthesis Adapted to Maximize Strength and Durability of Prostheses--Bone Cement Interface; and Methods of Forming Same, to Simon Raab.
17. U.S. Pat. No. 5,014,494, Method of Sterilizing Medical Articles, to Robert D. George.
18. U.S. Pat. No. 5,137,688, Irradiated Articles Molded From Polycarbonate-Polyamide Blends, to James L. DeRudder.
19. U.S. Pat. No. 5,879,400, Melt-Irradiated Ultra High Molecular Weight Polyethylene Prosthetic Devices, to Edward W. Merrill et al.
20. U.S. Pat. No. 6,017,975 Process for Medical Implant of Cross-linked Ultrahigh Molecular Weight Polyethylene Having Improved Balance of Wear Properties and Oxidation, filed Aug. 15, 1997, to Kenneth Ashley Saum, et al.
Foreign Patents
21. E.P. Patent No. 0722973 A1, Chemically Crosslinked Ultrahigh Molecular Weight Polyethylene for Artificial Human Joints, to Ron Salovey, et al.
22. W.O. Patent No. 97/29793, Radiation and Melt Treated Ultra High Molecular Weight Polyethylene Prosthetic Devices, to W. Merrill, et al.
23. W.O. Patent No. 98/01085, Crosslinking of Polyethylene for Low Wear Using Radiation and Thermal Treatments, to Fu-Wen Shen, et al.
The above references teach the general concepts involved in forming or consolidating UHMWPE resin directly into a part or a stock form from which the part is made, gamma or other irradiation of the part or the stock form and subsequent heat treating (annealing or remelting) of the part or stock form. The disclosures of these above-listed references are incorporated herein for purposes of establishing the nature of UHMWPE resin, the irradiation steps and options and the heat treating steps and options. Applicant also incorporates by reference U.S. application Ser. No. 09/328,080 filed Jun. 8, 1999 titled CROSS-LINKED MOLDED PLASTIC BEARINGS naming Todd Smith and Donald McNulty as coinventors.